ࡱ> }~ 3bjbj 9xikxik* 8m^U:UUUUUUULX[UU4U%%%^U%U%%OlR@ѫF$M B5Q*T.U0^U_QJ[![TR[RD%UU=#^U[ K: OFFICE USETRIAL REF NUMBERPROTOCOL NUMBERREPORT DUE DATE Protocol Review Application 91Ƭ Academic Complex APPLICATION TO CONDUCT A CLINICAL TRIAL/EVALUATION IF THIS FORM WAS GENERATED ELECTRONICALLY, PLEASE COMPLETE THE FOLLOWING DECLARATION: I/We, the Applicant(s) have not altered this form IN ANY WAY: _______________ ________________ (Signature - Company) Name _______________ ________________ GENERAL INFORMATION (Signature - Investigator) Name Name of Applicant: (Please insert names of both Company and Investigator) COMPANY Name of Company: Postal Address: .. Represented by: . Designation: . Telephone.Fax number: E-mail HOSPITAL MEDICAL OFFICER / PRINCIPAL INVESTIGATOR Name:. Designation: . Address: TelephoneFax number: .. E-mail: ... NATIONAL / PRINCIPAL INVESTIGATOR (If applicable if not applicable please fill in N/A where appropriate) NAME: Prof/Dr/Mr/Miss/Ms CO-INVESTIGATOR SUB INVESTIGATORS 1.2 Protocol Name / Number: . 1.3 Test products and mode of application: i) ii) . iii) . 1.4 Is the test product pharmaceutical? YESNOIf Yes: (1) Product registered: South African Health Products Regulatory Authority (SAHPRA) Registration No./s.: (2) Product unregistered: * SAHPRA Trial Approval No.: ..* (Attach official SAHPRA approval letter) Non-Pharmaceutical State registration/code number: Indicate object of the Trial/Evaluation: 1.7 Outline Details of Previous Trials/Evaluations Conducted If Any: YESNO If Yes, give details (i.e. dates, sites, sample sizes) 1.8 What is the title of the trial / evaluation? .. .. .. 1.9 Estimated period of trial/evaluation at 91Ƭ sites: .. 1.10 RESEARCH UNIT DETAILS: NAME OF PRINCIPAL INVESTIGATORHOSPITAL/ DEPARTMENTDEPARTMENTAL HEADNUMBER OF PATIENTS1.11 Indicate Expected Date of Final Trial / Evaluation Report: DAYMONTHYEAR1.12 COSTS 1.12.1 State the estimated costs of the trial to the Hospital: R 1.12.2 If the applicant is a firm, will the firm bear all their costs? YESNO 1.12.3 If the applicant is a medical officer or employee of the Gauteng Department of Health, please state if sufficient funds have been made available for this trial: YESNO 1.13 Will sufficient test material be supplied? YESNO 1.14 Will you be funding all laboratory investigations? YESNO Please state investigations to be covered .. .. .. If No: Please state investigations not covered and reason/s why excluded .. .. .. Are there additional costs for the hospital involved? YESNOIf Yes, explain . . . Will you be funding all other non-laboratory investigations required for the trial? YESNOPlease state investigations to be covered .. .. .. If No: Please state investigations not covered and reason/s why excluded .. .. .. 1.16 What other equipment will be required for the trial? .. .. What arrangements have been made for those investigations and with whom? .. .. .. 1.18 Will investigations in 1.15 be undertaken directly or through the 91Ƭ Health Consortium? .. 1.19 Will the Sponsor be paying costs in 1.15 and 1.16 directly or through the 91Ƭ Health Consortium? .. 1.20 Who will be undertaking investigations in 1.16? .. Are any non-routine precautionary measures pertaining to the study drug/procedure to be taken? YESNOIf Yes, by whom?.. What net cost savings to Provincial budgets are anticipated from this study: Per enrolled patient In total for all projected enrolees .. 2. AGREEMENT BY APPLICANT The applicant(s) agree(s) as follows: To conduct the trial / evaluation recorded in and under the conditions set out in this application form. To conduct this trial / evaluation at no additional expense to the Gauteng Department of Health whatsoever. To accept full responsibility for any or all harmful effects on a patient using my /our / the product recorded on the application form. To exonerate the Gauteng Department of Health from all liability of damages, legal, financial or otherwise, including any claim instituted by a patient using my/our/the product recorded in this application form, but excluding negligence on the part of the medical officer and/or employee of the Gauteng Department of Health using the said product on the patient(s) concerned, provided that the medical officer and/or employee is not the applicant. To inform the Gauteng Department of Health and other relevant authorities should it be deemed necessary to deviate from protocol or stop this trial/evaluation. To make available without delay all the results of this trial / evaluation to the Gauteng Department of Health. I / We understand that the Gauteng Department of Health having allowed this trial / evaluation to be conducted places himself or herself or the Gauteng Department of Health under no obligation whatsoever and to leave the final choice of the institution where the trial/evaluation will be conducted to the Gauteng Department of Health. APPLICANT - (PRINCIPAL INVESTIGATOR) DATESIGNATUREINITIAL / (S)SURNAMEDAYMONTHYEAR Designation / Rank: ____________________________________________ COMPANY MANAGING DIRECTOR OR REPRESENTATIVEDATESIGNATUREINITIAL / (S)SURNAMEDAYMONTHYEAR Designation/Rank: ____________________________________________ NB: TWO WITNESSES REQUIRED WITNESSESDATESIGNATUREINITIAL / (S)SURNAMEDAYMONTHYEAR FOR MORE THAN ONE TRIALIST PER STUDY, PLEASE COPY THIS PAGE APPROPRIATELY INITIAL CONSENT BY DEPARTMENTAL HEAD (Please note: That when the Investigator is the Head of Department he/she CANNOT SIGN Section 3 it must be completed by the Section Head) I . Head of theDepartment of .. Hospital, in consultation with the Hospital CEO / Superintendent of this Hospital, grant permission to submit an application to conduct a trial/evaluation to the Chairperson of the relevant Ethics Committee. The officer conducting the trial/evaluation will be Designation/Rank: . HEAD OF DEPARTMENTDATESIGNATUREINITIAL / (S)SURNAMEDAYMONTHYEAR 4. DECLARATION BY TRIALIST: I undertake that I have read and understood the protocol and other documentation relating to the trial. I declare that to the best of my knowledge using this drug in this clinical indication does not unduly compromise the safety of the patient. 4.3 I agree to obtain written informed consent from patients who are legally competent in all cases. 4.4 I shall under no circumstances begin with the Trial prior to approval from the Hospital/University Ethics Committee, the Hospital CEO / Superintendent and the Gauteng Department of Health. 4.5 I agree to obtain consent from the company and relevant authorities in writing, should I wish to deviate from protocol, in any manner. 4.6 I agree to render a full report of my findings at the end of the trial and to render a progress report of my findings as instructed to Head Office, Gauteng Provincial Administration and agree not to publish any report relevant to the trial without the permission of the Gauteng Department of Health. Full acknowledgement will also be given to the Gauteng Department of Health. TRIALISTDATESIGNATUREINITIAL / (S)SURNAMEDAYMONTHYEAR  HEAD OF DEPARTMENTDATESIGNATUREINITIAL / (S)SURNAMEDAYMONTHYEAR REMARKS: UNIVERSITY ETHICS COMMITTEE APPROVAL: (To be signed by Ethics Committee Chairperson- forwarded from the Ethics Office for signature on approval) CHAIRPERSON OF ETHICS COMMITTEEDATESIGNATUREINITIAL / (S)SURNAMEDAYMONTHYEAR REMARKS: APPROVAL BY HOSPITAL CEO / SUPERINTENDENT: The Sponsor / Investigator must obtain the signature of the Hospital CEO / Superintendent / Clinic Manger / District Research Committee AFTER the Chairperson of the Ethics Committee has signed Section 5 above. I . CEO / Superintendent of .... . Hospital hereby agree that this trial / evaluation be conducted in the .department of this hospital. The officer conducting the trial will be The officer controlling supplies will be. HOSPITAL CEO / SUPERINTENDENTDATESIGNATUREINITIAL / (S)SURNAMEDAYMONTHYEAR IMPORTANT NOTIFICATION: STEPS TO BE TAKEN: If trial is being conducted in Provincial Health Facilities: Approval from the Hospital CEO / Clinic Manager / District Research Committee (whichever is applicable) must be obtained. Please submit this form, the Protocol/Expert Review and Ethics Approval Letter to the Hospital CEO / Clinic Manager / District Research Committee (whichever is applicable) for signature/approval. The study must be submitted onto The National Health Research Database (NHRD) for record purposes. 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